Method treating erectile dysfunction via a penile implant with dilatant liquid

ABSTRACT

A method treating erectile dysfunction includes implanting a penile implant including a first bladder and a second bladder, the second bladder filled with a liquid having a rest viscosity. The method additionally includes increasing a pressure in the first bladder of the penile implant from a first pressure to a second pressure, and increasing a viscosity in the liquid from the rest viscosity to a second viscosity greater than the rest viscosity. The method further includes maintaining the first bladder of the penile implant at the second pressure and the liquid in the second bladder at the second viscosity.

BACKGROUND

An implanted penile prosthetic is effective in relieving erectiledysfunction in men.

A penile prosthetic typically includes one or more cylinders that areimplanted in the corpora cavernosa of the penis, a liquid reservoirimplanted in the abdomen that communicates with the cylinder(s), and apump, often located in the scrotum, that is employed to move liquid fromthe liquid reservoir into the cylinder(s).

In a typical application, the user squeezes a bulb of the pump multipletimes to incrementally draw liquid out of the liquid reservoir, into thebulb, and eventually into the cylinders. The repeated squeezing of thebulb moves the liquid from the reservoir into the cylinders, whichincrementally deflates the reservoir and incrementally inflates thecylinder(s) to eventually provide the user with an erect penis. The usermay return the penis to its flaccid state by selectively transferringthe liquid from the cylinder(s) back into the reservoir.

The above-described penile prosthetics have proven effective inrelieving erectile dysfunction in men. However, men have expressed acontinuing desire for more spontaneous, efficient, and effective penileprostheses.

SUMMARY

One aspect provides a body implantable penile prosthetic assemblyincluding a penile implant and a reservoir. The penile implant includesa first bladder and a second bladder, where the second bladder containsa dilatant liquid. The reservoir is connectable with the first bladderof the penile implant. The fluid transferred from the reservoir into thefirst bladder of the penile implant imposes a shear on the dilatantliquid in the second bladder of the penile implant to increase viscosityin the dilatant liquid and harden the penile implant.

One aspect provides a method treating erectile dysfunction. The methodincludes implanting a penile implant including a first bladder and asecond bladder, the second bladder filled with a liquid having a restviscosity. The method additionally includes increasing a pressure in thefirst bladder of the penile implant from a first pressure to a secondpressure, and increasing a viscosity in the liquid from the restviscosity to a second viscosity greater than the rest viscosity. Themethod further includes maintaining the first bladder of the penileimplant at the second pressure and the liquid in the second bladder atthe second viscosity.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments andtogether with the description serve to explain principles ofembodiments. Other embodiments and many of the intended advantages ofembodiments will be readily appreciated as they become better understoodby reference to the following detailed description. The elements of thedrawings are not necessarily to scale relative to each other. Likereference numerals designate corresponding similar parts.

FIG. 1 is a perspective view of one embodiment of a body implantablepenile prosthetic assembly including a pump connected to a reservoir anda penile implant.

FIG. 2 is a perspective view of the pump illustrated in FIG. 1.

FIG. 3 is a cross-sectional view of the pump illustrated in FIG. 2.

FIG. 4 is a cross-sectional view of one embodiment of the penile implantillustrated in FIG. 1 showing a bladder containing a dilatant liquid.

FIG. 5 is a schematic view of the body implantable penile prostheticassembly illustrated in FIG. 1 implanted in a patient.

FIG. 6 is a perspective view of one embodiment of a body implantablepenile prosthetic assembly including a reservoir coupled to a penileimplant.

FIG. 7A is atop cross-sectional view and FIGS. 7B-7C are sidecross-sectional views of a valve mechanism located between the reservoirand the penile implant illustrated in FIG. 6.

FIG. 8 is a cross-sectional view of one embodiment of the penile implantillustrated in FIG. 6 showing a bladder containing a dilatant liquid anddisposed around a peristaltic pump/bladder.

FIG. 9 is a cross-sectional side view of the penile implant illustratedin FIG. 8 peristaltically compressed to draw fluid from the reservoirinto the peristaltic pump/bladder.

FIG. 10 is a cross-sectional side view of the penile implant illustratedin FIG. 9 after peristaltic activation has hardened the dilatant liquidcausing the implant to become erect.

FIG. 11 is a schematic view of the body implantable penile prostheticassembly illustrated in FIG. 6 implanted in a patient.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

It is to be understood that the features of the various exemplaryembodiments described herein may be combined with each other, unlessspecifically noted otherwise.

The term “proximal” as employed in this application means that thereferenced part is situated next to or near the point of attachment ororigin or a central point: as located toward a center of the human body.The term “distal” as employed in this application means that thereferenced part is situated away from the point of attachment or originor the central point: as located away from the center of the human body.A distal end is the furthest endmost location of a distal portion of athing being described, whereas a proximal end is the nearest endmostlocation of a proximal portion of the thing being described. Forexample, the glans penis is located distal, and of the crus of the penisis located proximal relative to the male body such that a distal end ofa corpora cavernosum of the patient extends about midway into the glanspenis.

A dilatant liquid is a fluid having a viscosity that increases as shearis applied to the dilatant liquid. A dilatant liquid will thus “harden”or become thicker when shear stress is applied to the dilatant liquid,and in some cases this hardening is nearly instantaneous in response tothe applied stress. The dilatant liquid will remain hardened in thethickened state until the shear stress is removed, which provides thedilatant liquid with reversible thickening properties. For example, adilatant liquid with an “at-rest” viscosity will thicken/harden to ahigher viscosity when a shear stress of 10 psi is applied to thedilatant liquid; when the shear stress is reduced, the viscosity will bereduced, and at zero applied shear stress the dilatant liquid willreturn to the lower at-rest viscosity.

In contrast, one definition of a rheopexic fluid is a fluid having aviscosity that increases with a rate of change of shear applied to therheopexic fluid. A rheopexic fluid will thus “harden” or become thickerin the presence of changing shear stress applied to the rheopexic fluid.One definition of a rheopexic fluid is a fluid having a viscosity thatis time-dependent upon application of stress. This kind of rheopexicfluid requires that the stress be applied for a significant portion oftime, from several seconds to several minutes depending on formulation,for any change in viscosity to occur. The rheopexic fluid will return toits initial lower viscosity state whenever the applied stimulationceases. For example, a rheopexic fluid with a constant shear stress of10 psi will not respond with an increase in viscosity since a rheopexicfluid responds to the rate of change in the shear stress. In otherwords, a rheopexic fluid requires continuous stimulation (or a shearstress that is continually changing) in order to exhibit the hardenedstate. A rheopexic fluid thickens in response to changing shear stresssuch that even if the shear stress is relatively high at 10 psi therheopexic fluid will not thicken since the constant shear stress of 10psi has a rate of change of shear that is zero.

Embodiments provide a penile implant having a first bladder and a secondbladder, where the second bladder contains a dilatant liquid. Areservoir is connected with the first bladder of the penile implant.When fluid is transferred from the reservoir into the first bladder, ashear is imposed on the dilatant liquid in the second bladder. The shearon the dilatant liquid increases the viscosity of the liquid in thesecond bladder resulting in a hardening of the penile implant. Since aportion of the penile implant is filled with dilatant liquid, thereservoir can be configured as a liquid-sparing reservoir that issmaller than a typical reservoir and more comfortable to implant intothe abdomen of the patient. To this end, the prosthetic device is morecomfortable for the patient. In some embodiments, the prosthetic deviceincludes a pump for moving liquid from the reservoir into the firstbladder. The liquid-sparing reservoir configures the prosthetic deviceto operate with fewer squeezes of the pump, which improves comfort andconvenience for the user.

Embodiments provide a penile implant having a first bladder and a secondbladder, where the second bladder contains a dilatant liquid. In anat-rest state, the dilatant liquid will configure the implant to beflaccid. When the user desires an erection, the implant is configured toharden to an erect state in response to shear applied to the dilatantliquid. For example, an erection is achievable by employing a pump toincrease the pressure in the first bladder of the implant to apply shearto the dilatant liquid, perhaps in expectation of coitus. In thisregard, the user can apply the shear stress to the implant and harden itto the erect state prior to having relations, and upon cessation of thepumping of the liquid into the first bladder, the implant will maintainin the hardened erect state until the use selectively relieves thepressure in the first bladder.

FIG. 1 is a perspective view of one embodiment of a penile prostheticassembly 20. The penile prosthetic assembly 20 includes a pump 22connected to a reservoir 24 and a penile implant 26, and a releasemechanism 28 connected between the reservoir 24 and the penile implant26.

Generally, the pump 22 is implanted into the scrotum of the user andincludes the release mechanism 28 the reservoir 24 is implanted withinthe abdomen of the user, and the implant 26 is implanted within thepenis. The pump 22 is operable to transfer liquid from the reservoir 24into the penile implant 26. The penile implant 26 includes one or morebladders that contain a dilatant liquid configured to respond to shearstress, for example shear stress initiated by the flow of liquid fromthe reservoir 24 into the penile implant 26. The dilatant liquid hardens(exhibits increased viscosity) in the presence of shear stress to createan erection in the penile implant 26. The release mechanism 28 isoperable to selectively allow the liquid pumped into the penile implant26 to return to the reservoir 24 and thus return the penile implant 26to a flaccid state.

The reservoir 24 is connected to the pump 22 via tubing 30, which in oneembodiment is kink resistant tubing 30. The reservoir 24 contains aNewtonian liquid (i.e., a non-shear-thinning liquid) such as water orsaline. In one embodiment, the assembly 20 is sealed against leakage ofliquids from the cylinders 32 of the implant 26 or reservoir 24 andincludes a sufficient amount of liquid in the reservoir 24 to activatethe dilatant liquid in the implant 26 without undesirably accessing theassembly 20 after implantation to inject more liquid.

The reservoir 24 is sized to hold a volume of liquid between about50-350 ml. In one embodiment, the reservoir 24 is provided as asubstantially cylindrical reservoir formed from an elastic, flexiblepolymer with a wall thickness of between 0.010-0.060 inches. In oneembodiment, the reservoir 24 is provided as a “cloverleaf” style ofreservoir having multiple leaves that may be folded one against theother to compactly fold the reservoir 24 for implantation into theabdomen of the user.

In one embodiment, the cylinders 32 of the penile implant 26 eachcontain a volume of dilatant liquid of between 50-70 nit and thereservoir 24 is a liquid-sparing reservoir that is sized to contain avolume of about 70 mL. In one embodiment, the first bladder 62 and thesecond bladder 64 combine to contain an erection volume of liquid(dilatant liquid plus saline) and the reservoir 24 is a fluid-sparingreservoir sized to contain at most 75% of the erection volume of liquid.In one embodiment, the first bladder 62 and the second bladder 64combine to contain an erection volume of liquid and the reservoir 24 isa fluid-sparing reservoir sized to contain at most 50% of the erectionvolume of liquid. Configuring the reservoir 24 as a liquid-sparingreservoir that contains approximately half of the erection volume of theimplant allows the reservoir 24 to be smaller and more comfortablyimplanted in the patient, whether in the abdominal area or othersuitable areas. Suitable reservoirs are available from Coloplast Corp.,Minneapolis, Minn.

In one embodiment, the penile implant 26 includes a pair of inflatablecylinders 32 that are sized to be implanted into the penis. Each of thecylinders 32 includes at least one bladder containing dilatant liquidand at least one bladder that is connected to the pump 22 by a tube 34.Each of the cylinders 32 includes a proximal end 36 opposite a distalend 38. During implantation, the proximal end 36 (also called a reartip) is implanted toward the crus of the penis and the distal end 38 isimplanted within the glans penis. The cylinders 32 are fabricated frommaterial configured to collapse and be flexible when the cylinders 32are deflated to provide the penis with a flaccid state and expand whenthe cylinders 32 are hardened to provide the penis with an erection.Suitable material for fabricating the cylinders 32 includes silicone,polymers such as urethanes, blends of polymers with urethane, copolymersof urethane, or the like. Suitable cylinders are available fromColoplast Corp., Minneapolis, Minn.

FIG. 2 is a perspective view of the pump 22. The pump 22 includes a pumpbulb 40 connected to a pump body 42 that houses the release mechanism 28(FIG. 3). The pump body 42 has a pair of inflation ports 46 that connectwith the cylinders 32 via the tubes 34 (FIG. 1), and an exhaust port 44that connects with the reservoir 24 via the tube 30. The pump 22 isfabricated from material suitable for body implantation, such assilicone or the urethane-based materials described above for thecylinders 32 or the reservoir 24.

In one embodiment, the release mechanism 28 is integrated within thepump body 42. The pump body 42 is deformable and includes a first touchpad 50 opposite a second touch pad 52. The touch pads 50, 52 may have acircular shape or a non-circular (e.g., elliptical) shape, and othershapes for the touch pads 50, 52 are also acceptable. The pump body 42houses or maintains valves (described below) that areactivated/deactivated by pressing one or both of the touch pads 50, 52.In one embodiment, the pads 50, 52 are configured for one-touchdeformation of the pump body 42 such that finger pressure applied to oneof the pads 50, 52 by the implant user deforms the pump body 42 to allowliquid to flow around one or more of the internal valves and back to thereservoir 24 for rapid deflation of the cylinders 32.

In one embodiment, the pump bulb 40 is flexible and includes a pleatedaccordion structure that allows the pump bulb 40 to collapse andrecover. The pump bulb 40 is operable to draw liquid from the reservoir24 and transfer the liquid into the cylinders 32 (FIG. 1).

FIG. 3 is a cross-sectional view of the pump 22. The pump 22 includes aninlet valve 54 disposed within the pump body 42 that communicatesbetween the reservoir 24 and the pump bulb 40, an exhaust valve 56disposed within the pump body 42 that communicates between the pump bulb40 and the cylinders 32, and an anti-autoinflation (AAI) valve 60disposed in the pump bulb 42 transversely between the inlet valve 54 andthe exhaust valve 56.

The inlet valve 54 includes a ball 70 that is biased into contact with asurface 72 by a spring 74. The ball 70 is configured to be displacedfrom the surface 72 (thus compressing the spring 74) when liquid flowsfrom the reservoir 24 through the inlet tube 44 and into the pump bulb40. When the liquid flow from the reservoir 24 is reduced, or morespecifically, when the pressure driving the liquid flow from thereservoir 24 is reduced, the spring 74 biases the ball 70 into contactwith the surface 72 to seat the ball on the surface 72 and blockbackflow of the liquid from the bulb 40 back to the reservoir 24. Inthis manner, the inlet valve 54 is provided as a one-way inlet valvethat allows liquid to flow from the reservoir 24 to fill the bulb 40.

The exhaust valve 56 includes a ball 80 that is biased into contact witha surface 82 by a spring 84. The ball 80 is configured to be displacedfrom the surface 82 (thus compressing the spring 84) when liquid flowsfrom the pump bulb 40 through the exhaust valve 56 toward the cylinders32. For example, compressing the pump bulb 40 ejects liquid from thepump bulb 40, which unseats the ball 80 from the surface 82 to allow theliquid to flow past the ball 80 and the AAI valve 60 into the cylinders32. Pumping the bulb 40 thus draws liquid from the reservoir 24, pastthe ball 80, into the bulb 40, and ejects the liquid into the cylinders32 (FIG. 1). The spring 84 biases the ball 80 into contact with thesurface 82 to block backflow of liquid from the cylinders 32 into thepump bulb 40. In this manner, the exhaust valve 56 is provided as aone-way exhaust valve.

In one embodiment, the pump body 42 is an elastomeric chamber moldedaround the AAI valve 60. The AAI valve 60 is configured to allow liquidto flow from the reservoir 24 into the pump bulb 40 and out the pumpbulb 40 into the cylinders 32 during inflation of the bladder 62 (FIGS.4 and 5). The AAI valve 60 is also configured to allow for the rapiddeflation of the bladders 62 in the cylinders 32. For example, in oneembodiment pressing on the activation surface 52 positions the AAI valve60 to allow fluid to flow from the bladders 62 through the pump body 42,bypassing the pump bulb 40, and flowing directly back into the reservoir24. In addition, the AAI valve 60 is configured to prevent undesirableautoinflation of the cylinders 32 by preventing fluid from flowing fromthe reservoir 24 directly into the bladders 62 (i.e., undesirablybypassing the pump bulb 40).

FIG. 4 is a cross-sectional side view of one embodiment of a cylinder 32of the penile implant 26. One cylinder 32 of the penile implants 26 isdescribed with the understanding that the typical application wouldinclude two implanted cylinders 32, one in each of the two corporacavernosa of the patient. The penile implant 26 is substantiallycylindrical or otherwise suited to be implantable into a corporacavernosum of the penis.

The penile implant 26 includes a proximal tip 60, a first bladder 62connected to the proximal tip 60 and communicating with the reservoir 24via a conduit 70 that connects with the tubing 34, and a second bladder64 containing dilatant liquid DL that is disposed inside of the firstbladder 62. Suitable dilatant liquids DL include oobleck (a solution ofcorn starch and water), a suspension of silica in water, or a solutionof polyvinyl acetate/borax/water. One suitable oobleck solution is 2parts corn starch in 1 part water that forms a non-Newtonian solutionthat is configured to become thicker/harden in a nearly instantaneousmanner when shear stress is applied to the oobleck solution.

The penile implant 26 is illustrated with the first bladder 62 displaceda distance away from the second bladder 64 for improved descriptiveclarity, although it is to be understood that a flaccid implant 26(e.g., with the dilatant liquid not activated by shear) would have thebladder 62 relaxed in a wrinkled or crumpled state where the bladder 62might even contact the second bladder 64. In one embodiment, the firstbladder 62 and the second bladder 64 are arranged in a coaxial mannerwith the first bladder 62 disposed around the second bladder 64 of thepenile implant 26. In one embodiment, the first bladder 62 and thesecond bladder 64 are arranged in a coaxial manner with the secondbladder 64 disposed around the first bladder 62. In one embodiment, thefirst bladder 62 and the second bladder 64 are arranged in aside-by-side orientation.

The proximal tip 60 is a substantially solid proximal tip that is formedto receive the bladders 62, 64. The first bladder 62 extends from aproximal end of 74 that is connected to the proximal tip 60 to a distalclosed end 76. In one embodiment, the first bladder 62 is provided as asealed and substantially enclosed bladder, and the second bladder 64 isdisposed inside of the first bladder 62. The second bladder 64 extendsbetween a proximal end 78 that is connected with the proximal tip 60 anda closed distal end 80.

In one embodiment, an optional rear tip extender 90 is provided that isattachable to a proximal end portion 92 of the proximal tip 60. Theoverall length of a penis includes an internal body portion located at aproximal end (termed the crus of the penis) to an external distal end(termed the glans penis). Naturally, the length of the penis differsbetween patients. The optional rear tip extender 90 is provided toextend the penile implant 26 a greater distance in the proximaldirection, which allows the penile prosthetic to extend into the crus ofthe penis for an improved fit.

Suitable materials for fabricating the penile implant 26 includepolymers, with two examples being polyurethane or silicone. For example,in one embodiment the bladder 62 is fabricated from a urethane materialsold under the trademark BIOFLEX available from Coloplast Corp.,Minneapolis, Minn. and the distal end 76 of the bladder 62 issubsequently dipped in additional urethane material that cures toprovide a desirable leading-end shape to the bladder 62. In oneembodiment, the bladder 62 is formed from silicone, which is dissimilarto urethane. To facilitate the attachment of these two dissimilarmaterials, in one embodiment the silicone bladder is coated with fumedsilica to prepare the surface for bonding with a urethane distal endtip.

FIG. 5 is a schematic side view of the penile prosthetic assembly 20implanted in a user. The cylinders 32 are implanted in the penis P withthe proximal end 36 inserted near the crus and the distal end 38implanted within the glans. The smaller, liquid-sparing reservoir 24 isimplanted within the abdomen A and the pump 22 is implanted within thescrotum S. The penile prosthetic assembly 20 is operable consistent withthe description above to transfer liquid from the reservoir 24 into thefirst letter 62 to impart a shear on the dilatant liquid in the bladder64, thus hardening the penile implant 26 to create an erection.

In one exemplary implantation approach, the groin area of the patient iscleaned, shaved, and suitably prepped with, for example, a surgicalsolution prior to draping with a sterile drape. A retraction device,such as a retractor sold under the trademark LONE STAR available fromLone Star Medical Products of Stafford, Tex., is placed around thepenis. Thereafter, the surgeon forms an incision to access the corporacavernosum of the patient, where suitable examples of incisions includeeither an infrapubic incision or a transverse scrotal incision.

The infrapubic incision is initiated between the umbilicus and the penis(i.e., above the penis), whereas the transverse scrotal incision is madeacross an upper portion of the patient's scrotum. As an example of thetransverse scrotal approach, the surgeon forms a 2-3 cm transverseincision through the subcutaneous tissue of the median raphe of theupper scrotum and dissects down through the Dartos fascia and Buck'sfascia to expose the tunicae albuginea of the penis.

Thereafter, each corpora cavernosum is exposed in a corporotomy where asmall (approximately 1.5 cm) incision is formed to allow the surgeon toaccess and dilate the corpora cavernosum. The corpora cavernosum isdilated distally toward the glans and proximally toward the crus with asuitable tool to create a space for the penile implant 26. For example,the surgeon begins dilation of both the distal and proximal corporacavernosum by introducing an 8 mm dilator into the spongy tissue of thecorpora with sequential progression to about a 14 mm dilator, each ofwhich are introduced and pushed distally toward the glans penis andproximally toward the crus of the penis. The surgeon measures a lengthof the dilated corpora cavernosum to facilitate selection of the properlength of the penile implant 26 and adjusts the length of the implant byadding an appropriately sized rear tip extender 90 (FIG. 4) as desired.

After dilation of the corpora cavernosa, a deflated penile implant 26(FIG. 4) is inserted into the prepared corporotomy. The surgeon maypalpate the end of penis at the subcoronal area to locate the distal end80 of the penile implant 26 to ensure proper interior placement of theprosthesis in the patient.

The reservoir 24 is connected to the penile implant 26 via the tubing 30(FIG. 1) and the surgeon inflates the bladder 62 with liquid from thereservoir 24 to shear thicken the dilatant liquid DL in the secondbladder 64 to ensure proper function of the system 20. Thereafter, theliquid-sparing reservoir 24 is filled with an appropriate volume ofliquid and implanted into the abdomen, for example in the space ofRetzius, and the surgical site is closed to allow the patient to heal.

The pump 22 is operable to transfer liquid from the reservoir 24 intothe first bladder 62. Filling the first bladder 62 with liquid creates ashear stress on the second bladder 64 containing the dilatant liquid DL,and the dilatant liquid DL responds by shear thickening to a hardenedstate. Once the first bladder 62 is pressurized, the shear (i.e., threeper unit area) of the pressurized liquid in the first bladder 62 willimpose a substantially constant shear on the dilatant liquid DL, in thesecond bladder 64, which will increase the viscosity in the dilatantliquid DL and harden the penile implant 26. That is to say, the shearapplied to the dilatant liquid can be constant such that the rate ofshear applied to the dilatant liquid is zero and the implant 26 willmaintain the erect, hardened state.

In one embodiment, the pump 22 transfers saline solution from thereservoir 24 into the first bladder 62 such that the pump 22 transfersapproximately half of an erection volume of liquid from the reservoir 24into the implant 26 and yet fully inflates the implant 26 to an erectstate.

In one embodiment, a method treating erectile dysfunction includesimplanting a penile implant 26 including a first bladder 62 and a secondbladder 64, the second bladder 64 filled with a liquid having a restviscosity; increasing a pressure in the first bladder 62 of the penileimplant 26 from a first pressure to a second pressure; increasing, aviscosity in the liquid from the rest viscosity to a second viscositygreater than the rest viscosity; and maintaining the first bladder 62 ofthe penile implant 26 at the second pressure and the liquid in thesecond bladder 64 at, the second viscosity. For example, in oneembodiment the pressure and the first bladder 62 is increased from aboutzero PSIG to a second pressure of about 15 psi and the viscosity of thedilatant liquid increases by at least an order of magnitude to providethe implant 26 with a column strength of about 4-15 pounds force.

FIGS. 6-11 illustrate embodiments that provide an implantable penileimplant, that is configured as a peristaltic pump configured to transferliquid from an implanted reservoir into a first bladder of the penileimplant, which imparts a shear stress to a dilatant liquid stored in asecond bladder of the penile implant, thus causing the dilatant liquidto shear harden and creating an erection in the implant.

Peristaltic means a wavelike contraction of a tube or a tubularstructure between an entrance opening and an exit opening by whichcontents in the tube are forced to the exit opening. Peristalticcompression is a wavelike contraction that is provided, in one example,by pinching the tube with fingers (or a device) and sliding thefingers/device from near the entrance opening toward the exit opening.Peristaltic compression is referred to as a moving compression.

FIG. 6 is a perspective view of one embodiment of a penile prostheticsystem 120. The penile prosthetic system 120 (system 120) includes afluid reservoir 122, a pair of penile prosthetic pumps 124, and a checkvalve 126 connected between the fluid reservoir 122 and the penileprosthetic pumps 124. In one embodiment, the penile prosthetic pumps 124includes a first prosthetic pump 124 a that is implantable into a firstcorpora cavernosum of the penis and a second prosthetic pump 124 b thatis implantable into a second corpora cavernosum of the penis. Thereservoir 122 is implantable in the body, for example within the abdomenof the user. Tubing 128 is connected between the fluid reservoir 122 andthe check valve 126, and each of the prosthetic pumps 124 includestubing 130 connected to the check valve 126. Thus, the pumps 124communicate with the reservoir 122 via the tubing 128, 130.

FIG. 7A is a cross-sectional top view of one embodiment of the checkvalve 126. The check valve 126 includes a body 140, an inlet opening 142and an outlet opening 144, and a hall 146 that is biased against a seat148 by a spring 150. In one embodiment, the body 140 is a deformablebody molded or otherwise fabricated from a resilient/compressiblepolymer such as silicone or a thermoplastic polymer.

The check valve 126 is configured to allow fluid to be drawn from thereservoir 122 (FIG. 6) into the pumps 124 and impede or restrict thefluid from flowing out of the pumps 124 and back to the reservoir 122until this flow condition is selectively permitted by the user (asillustrated in FIG. 7B).

During an exemplary inflation of the pumps 124, the fluid is movedthrough the tubing 128 and the inlet opening 142 by a pumping conditionor a pressure condition that moves the fluid out of the reservoir 122with a pressure sufficient to displace the ball 146 off of the seat 148.The fluid moves through the outlet opening 144 and the tubing 130 andinto the penile prosthetic pumps 124 (FIG. 6).

FIG. 7B is a cross-sectional side view of the check valve 126illustrating that the fluid inside of the penile prosthetic pumps 124 isprevented from flowing back through the check valve 126 by the spring150 that biases the ball 146 against the seat 148. In this manner, thefluid employed to inflate the pumps 124 (FIG. 6) maintains the pumps 124in the inflated state until the user selectively manipulates the checkvalve 126 to allow deflation of the pumps 124.

FIG. 7C is a cross-sectional side view of the check valve 126illustrating user-manipulation of the check valve 126 to allow deflationof the pumps 124. In one embodiment, the user-manipulation of the checkvalve 126 includes an application of a force to deform the body 140.Deformation of the body 140 results in the ball 146 being displaced offof the seat 148, which allows the fluid to flow from the outlet opening144 past the ball 146 and back through the inlet opening 142 to thereservoir 122 (FIG. 6).

FIG. 8 is a cross-sectional side view of one embodiment of the penileprosthetic pump 124. One of the penile prosthetic pumps 124 is describedwith the understanding that the typical application would include twoimplanted pumps 124, one in each of the two corpora cavernosa of thepatient.

The penile prosthetic pump 124 includes a proximal tip 160, a firstbladder 162 connected to the proximal tip 160, and a peristaltic bladder164 (or peristaltic tubing 164) disposed inside of the first bladder162.

A conduit 170 is formed to provide a fluid communication path betweenthe reservoir 122 (FIG. 6) and the peristaltic bladder 164. In oneembodiment, the proximal tip 160 is a substantially solid proximal tipthat is formed to provide a chamber 172, with the conduit 170 extendingfrom the chamber 172 to the reservoir 122 and the peristaltic tubing 164communicating with and extending from the chamber 172.

The first bladder 162 extends from a proximal end 174 that is connectedto the proximal tip 160 to a closed distal end 176. In one embodiment,the first bladder 162 is sealed to contain a dilatant DL and theperistaltic tubing 164 is disposed inside of the first bladder 162.

The peristaltic tubing 164 has a proximal end 178 that is connected tothe proximal tip 160 and extends to the closed distal end 176.Peristaltic compression applied from the proximal end 178 toward thedistal end 176 of the peristaltic tubing 164 pumps fluid from thereservoir 122 (FIG. 6) into the second bladder or tubing 164 and impartsa shear stress (e.g., pressurizes) the dilatant liquid DL in the firstbladder 162.

In one embodiment, an optional rear tip extender 190 is provided that isattachable to a proximal end portion 192 of the proximal tip 160 toextend the penile prosthetic pump 124 a greater distance in the proximaldirection, which allows the penile prosthetic to extend into the crus ofthe penis for an improved fit.

Suitable materials for fabricating the penile prosthetic pump 124include polyurethane or silicone similar to the implant 26 describedabove.

FIG. 9 is a cross-sectional side view of the pump 124 peristalticallycompressed to draw fluid from the reservoir 122 into the tubing/bladder164 to stress the dilatant liquid DL in the bladder 162, which causesthe dilatant liquid to shear thicken to a hardened state to form anerection in the penile prosthetic pump 124. In one embodiment, the usercompresses the tubing/bladder 164 by squeezing the walls of theperistaltic tubing 164 together, and while squeezing the walls of theperistaltic tubing 164, slides the compression from the proximal end 178toward the distal end 176 of the tubing 164. The moving compression ofthe peristaltic wave W suctions the fluid from the reservoir 122,through the conduit 170, and increases the pressure of the fluid in theperistaltic tubing 164, which imparts a shear on the dilatant liquid inthe bladder 162. Subsequent, repeated moving compressions of theperistaltic wave W will drive more fluid into the tubing/bladder 164,which further increases the pressure in the tubing/bladder 164 to ensurethat the dilatant liquid in the bladder 162 is maintained in thehardened state.

FIG. 10 is a cross-sectional side view of the penile prosthetic pump 124showing the fluid been peristaltically pumped from the reservoir 122into the peristaltic tubing 164 and imparting a stress onto the dilatantliquid DL in the first bladder 162. The check valve 126 (FIG. 7B)impedes the flow of the fluid out of the peristaltic tubing 164, whichallows the penile prosthetic pump 124 to maintain the inflationpressure/stress against the dilatant liquid until the bladder 162 andthus maintain the erection. The user may selectively activate the checkvalve 26 to drain the fluid L from the tubing 164 back into thereservoir 24 to relieve the stress on the dilatant liquid in the bladder162 and return the implant 124 to a flaccid state.

FIG. 11 is a schematic view of the penile prosthetic system 120 with thereservoir 122 implanted in the patient's abdomen and a prosthetic pump124 implanted into each corpora cavernosum of the penis P.

The peristaltic tubing/bladder 164 is illustrated as being co-axiallylocated inside the first bladder 162 containing the dilatant liquid.Alternatively, embodiments provide for the first bladder 162 containingthe dilatant liquid to be co-axially enclosed inside the peristaltictubing/bladder 164 similar to the structure described above for theimplant 26.

Embodiments described above provide a body implantable penile prostheticassembly provide means for transferring a second liquid into a firstbladder of a penile implant, imposing a shear on a dilatant liquid inthe second bladder of the penile implant, and increasing a viscosity inthe dilatant liquid. Embodiments described above provide a bodyimplantable penile prosthetic assembly provide means for increasing apressure in the first bladder of the penile implant from a firstpressure to a second pressure and increasing a viscosity in the liquidfrom the rest viscosity to a second viscosity greater than the restviscosity, and maintaining the first bladder of the penile implant atthe second pressure and the liquid in the second bladder at the secondviscosity.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat a variety of alternate and/or equivalent implementations may besubstituted for the specific embodiments shown and described withoutdeparting from the scope of the present invention. This application isintended to cover any adaptations or variations of medical devices asdiscussed herein. Therefore, it is intended that this invention belimited only by the claims and the equivalents thereof.

1. A method treating erectile dysfunction, the method comprising:implanting a penile implant including a first bladder and a secondbladder, the second bladder filled with a liquid having a restviscosity; increasing a pressure in the first bladder of the penileimplant from a first pressure to a second pressure; increasing, aviscosity in the liquid from the rest viscosity to a second viscositygreater than the rest viscosity, and maintaining the first bladder ofthe penile implant at the second pressure and the liquid in the secondbladder at the second viscosity.
 2. The method of claim 1, whereinincreasing a pressure in the first bladder of the penile implant from afirst pressure to a second pressure comprises squeezing a pump bulbconnected between the penile prosthetic and a reservoir and transferringa fluid from the reservoir into the first bladder.
 3. The method ofclaim 1, wherein increasing a pressure in the first bladder of thepenile implant from a first pressure to a second pressure comprisesperistaltically transferring a fluid from a reservoir into the firstbladder.
 4. The method of claim 1, wherein the liquid in the secondbladder is a dilatant liquid and increasing a pressure in the firstbladder of the penile implant from a first pressure to a second pressurecomprises transferring a saline solution from a reservoir into the firstbladder and increasing a viscosity in the liquid from the rest viscosityto a second viscosity greater than the rest viscosity comprisesimparting a stress on the dilatant liquid in the second bladder with thesaline solution in the first bladder.
 5. A method treating erectiledysfunction, the method comprising: implanting into a penis an implantincluding a first bladder and a second bladder, the second bladderfilled with a dilatant liquid having a rest viscosity; transferring asaline solution from a reservoir into the first bladder and imparting astress on the dilatant liquid in the second bladder with the salinesolution transferred into the first bladder; increasing a viscosity inthe dilatant liquid from the rest viscosity to a second viscositygreater than the rest viscosity; and maintaining the dilatant liquid inthe second bladder at the second viscosity.
 6. The method of claim 5,wherein the first bladder and the second bladder of the implant combineto contain an erection volume of liquid to provide the implant with anerect state, and the reservoir is a liquid-sparing reservoir configuredto contain a volume of liquid that is approximately half of the erectionvolume.
 7. The method of claim 5, wherein transferring a saline solutionfrom a reservoir into the first bladder comprises squeezing a pump bulbconnected between the implant and the reservoir.
 8. The method of claim5, wherein transferring a saline solution from a reservoir into thefirst bladder comprises peristaltically transferring saline solutionfrom a reservoir into the first bladder.
 9. The method of claim 5,wherein transferring a saline solution from a reservoir into the firstbladder comprises transferring approximately half of an erection volumeof liquid from a reservoir into the implant and inflating the implant toan erect state.
 10. A method treating erectile dysfunction, the methodcomprising: implanting into a penis an implant including multiplebladders with at least one bladder sealed to contain a dilatant liquid;transferring a second liquid from a reservoir into one of the multiplebladders of the implant, stressing the dilatant liquid and hardening thedilatant liquid to provide the implant with an erection.